
Explore the basics of capsules, their gelatin shells, and differences from tablets, including swallowing ease, bioavailability, stability, and manufacturing considerations for large-scale production.
Explore hard and soft gelatin capsules, including enteric types, learn capsule sizes 000 to 5, and review gelatin manufacturing processes, acid and alkaline, with additives like coloring agents and pigments.
Master the seven-step process for hard gelatin capsule shells, from dipping solution preparation to printing. Grasp how viscosity, air-bubble control, coloring, drying, and trimming shape shell quality.
Explore capsule filling methods from hand and automated powder fills to liquid and semi-solid fills, including two-piece capsules, sealing, and uniformity considerations for nutraceuticals and clinical studies.
Learn in-process quality control for capsules, covering permeability, sealing potency, impurity content, weight variation and content uniformity, disintegration, dissolution, moisture permeation, microbial content, shelf life, and stability testing.
Identify the encapsulation speed operating range for reliable capsule filling, emphasizing good flow and consistent density, and apply IPQC tests, including disintegration, weight variation, dissolution, essay content, and uniformity.
Explore plant layout for hard and soft gelatin capsule manufacturing, detailing room flow, airlocks, temperature and humidity controls, and packaging, plus filling methods.
· Hard gelatin capsules are solid dosage forms in which one or more drug substance and/or inert materials are enclosed within a small shell. They are composed largely of gelatin and consist of two parts: the body designed to contain the drug and the diluent, and the cap that is approximately half as long as the body. Most capsule products manufactured today are of the hard gelatin type. It is estimated that the utilization of hard gelatin capsules to prepare solid dosage forms exceeds that of soft gelatin capsules by about 10-fold.
· Hard gelatin capsules are fabricated and supplied empty to the pharmaceutical industry by shell suppliers and are then filled in a separate operation. Manufacturing gelatin capsules involves a step by step process that requires strict quality control but before we delve into that let’s take a look at the raw materials used in the manufacture of hard gelatin capsules.
· The hard gelatin Capsule Manufacturing process contains 7-steps.
· Soft gelatin capsules have gained popularity in the pharmaceutical industry for human and veterinary use due to the many advantages it possesses over other commonly used solid dosage forms such as tablets, hard gelatin capsules etc. The bioavailability of hydrophobic drugs can be significantly increased when formulated into soft gelatin capsules.
· Many problems associated with tableting, including poor compaction and lack of content or weight uniformity, can be eliminated when a drug is incorporated into a soft gelatin capsule. Also, improved stability of drugs that are highly susceptible to oxidation can be achieved with soft gelatin capsule.
· These are manufactured by basic 5 processes.
· The learner shall be aware about the various process of Manufacture of Hard and Soft Gelatin Capsules and the equipment used.
The course shall be useful for the diplomate, graduate, postgraduate pharmacy and science job aspirants to enrich the knowledge required for the industrial capsule production process and their placements.